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WorksheetsPRO Clinical Training
Total questions: 7
Worksheet time: 5mins
Which of the following is true about the PENDL Study?
The secondary endpoints all tested superiority of the comparator PN vs the investigational BD 4mm PN
Needle bend was defined as being present if the bend rating was ≤ 2 (<10◦)
The primary endpoint of each study was to demonstrate noninferiority of the investigational BD 32 G x 4mm PN for participant-reported injection pain compared with each of the 33 G and 34 G comparator PNs.
The occurrence of leakage was defined as wet weight equivalent to ≤ 5% of the injection volume
In conclusion, the PENDL Study demonstrated that:
A. BD 32G 4mm PN was associated with less participant-reported pain and less force required for dose delivery vs Insupen 33G 4mm, Comfort EZ 33G 4mm, Insupen 34G 3.5mm, and Terumo 34G 4mm PNs.
B. Shorter PNs offer additional pain reduction benefit and force reduction benefit
C. No additional pain reduction benefit or force reduction benefit by thinner PNs compared with the investigational BD 32G PN
A and C are correct
Adjusted mean differences for perceived delivery force favored:
Terumo 34G
Insupen 33G
BD 32G
Insupen 34G
Comfort EZ 33G
The results of Studies 1 and 2 indicate that:
The investigational BD 32G x 4mm PN results in significantly less injection pain and less force to deliver the dose
The results are consistent with Study 1 for ethnically diverse participants and with Study 2 for participants with Japanese ethnicity
Leakage from the needle tip and injection site was significantly less compared with 2 of the 3 comparators (Study 1)
All of the above
What are the forces present during injection (Select all that apply)
Pen Needle - Skin Interface
Pen Needle - Muscle Interface
Thumb - Plunger Interface
Thumb - Syringe Interface
In RINI study, which of the following are observed skin fold techniques and hand grips (Select all that apply)
No pinch-up technique, uses one hand to grip pen and the index finger of the other to depress button
No pinch-up technique, uses 4 fingers to grip pen and index finger to depress button
Pinch-up technique with entire hand, uses 4 fingers to grip pen and index finger to depress button
Pinch-up technique with one finger and thumb, uses 4 fingers to grip pen and thumb to depress button
Which of the following is correct about the RINI study?
Five 32G 4mm needle was tested
Pen Needles can not deliver medication deeper than their assumed 4mm depth based on hub design and varying amounts of injection force
BD Nano's 2nd Gen's contoured design significantly reduced the variability of injection depth seen with other posted hub pen needle
IM injection risk decreases as injection depth increases
